Lighthouse II study finished recruitment phase with more than 400 participants

The Lighthouse II study finished recruiting. With currently 419 participants in the study, the study exceeded their goal of including 390 participants with ALS.

This milestone was reached as a collaborative team effort: 29 research centres from over the world participated in the study. Six sites are located in Europe, ten in the UK, and twelve in Australia and New Zealand. 

Leonard van den Berg, chairman of TRICALS and Coordinating Investigator (CI) for Lighthouse II: 

“We are very excited to announce that the Lighthouse II study has finished recruitment. With over 400 participants, we exceeded our goal of 390 patients. This is the first TRICALS sponsored study that has reached such a milestone. We look forward to continuing this study and moving one step closer to finding a cure for ALS.”

Ammar, UK CI for Lighthouse II:

“The Lighthouse II study is an ambitious project that we hope will advance the search for an effective treatment for ALS. We are grateful to all the participants for their time and effort in taking part.”

Julian Gold,  Australia and New Zealand CI for Lighthouse II:

“Participants and sites in Australia and New Zealand are pleased to be part of this important international collaboration, exploring new frontiers in finding the possible cause and an effective treatment for ALS.”

Lighthouse II study

The Lighthouse II study is a phase 3 clinical trial that compares the drug Triumeq to placebo.The study is investigating whether human endogenous retroviruses (HERVs) play a role in the development of motor neurone disease (MND) and to investigate whether targeting HERVs might have therapeutic potential in ALS. The investigational drug is called Triumeq. This drug is known to potentially target HERVs, as it is currently also being used to treat patients with HIV, a disease where human endogenous retroviruses also play a role.  

The Lighthouse II study therefore investigates whether Triumeq can inhibit the disease progression of ALS. The drug consists of three active substances joined together: dolutegravir, abacavir and lamivudine.  The predecessor of this study, the Lighthouse I study, has already shown that Triumeq is safe and well tolerated by people with ALS.   

Participants are randomly assigned into the active drug or placebo group, with a ratio of 2:1, with two people receiving the active drug and one person receiving a placebo. Participants are asked to come to the research center every three months for assessments for a maximum of 2 years.   

Since the recruitment of this study is finished, it is no longer possible for new participants to enter the study. 

Collaboration 

The Lighthouse II study wouldn’t have been possible without the parties below. The unique aspect about this study is that it has been funded by ALS patient organizations, foundations and governmental fundings.

• Ulla-Carin Lindquist stiftelse för ALS-forskning 
• Fundación Luzón 
• Research Motor Neurone 
• Slovenian Research Agency (ARRS)  
• Dutch ALS Foundation 
• Viiv Healthcare 
• Macquarie university 
• Kings College London 
• NIHR 
• My Name’5 Doddie Foundation 
• MND Association 
• Alan Davidson Foundation 
• FightMND 
• MND Australia 
• MND New Zealand
• ALS het licht uit gaat
• Miquel Valls Foundation